Z-0996-2023Class II

Vasoshield Syringe Packs, Model VH-5001

Name: Z-0996-2023 Vasoshield Syringe Packs, Model VH-5001
Creator: Maquet Cardiovascular, LLC
Published: 2022-12-22
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2022-12-22 / Open, Classified

FDA source

Maquet Cardiovascular, LLC began a recall of Vasoshield Syringe Packs, Model VH-5001 on 2022-12-22. FDA classified it as Class II and gives the reason as "Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0996-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-22
Posted: 2023-01-19
Recalling firm: Maquet Cardiovascular LLC
Product: Vasoshield Syringe Packs, Model VH-5001
Product code: GBX Catheter, Irrigation
Reason for recall: Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
FDA root cause: Under Investigation by firm
Action: URGENT MEDICAL DEVICE Removal notification letters dated 12/22/22 were sent to customers. Actions to be taken by the Customer: Our records indicate that you have received the Hemopro 2 with Vasoshield and Vasoshield Syringe from lots affected by this recall. Please, note that Distributed Affected Lot Numbers appear on the device shelf boxes only. Please examine your inventory immediately to determine if you have any of Hemopro 2 with Vasoshield and/or Vasoshield Syringe with the product code/lot numbers listed in this notice. LOT numbers can be found on the product label in the area circled in red. 1. Should you have any affected product lots as listed in this notification, please stop using and remove the complete device from areas of use. Distributed Affected Lot Number can be found on the device package. 2. Should you have un-used affected VH-4001 kits and/or VH-5001 (partial or full packs) you are eligible for credit. 3. Please forward this information to all current and potential Hemopro 2 with Vasoshield and Vasoshield Syringe users within your hospital / facility. 4. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. 5. Please contact Getinge Customer Service at 888-880-2874 between the hours of 6:00 a.m. and 5:00 p.m. Pacific Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. 6. Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet Cardiovascular, LLC /Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to (877)-804-2316. We apologize for any inconvenience this recall may cause. If you have any questions, please contact your Maquet Cardiovascular, LLC /Getinge representative or call the Geting
Quantity in commerce: 530 units US, 215 units OUS
Distribution: US Nationwide. Japan, Germany.
Product codes and lots: UDI-DI: 00607567700468; Serial Numbers: 25147126, 25151632, 25152389, 25152964, 25163138, 25162077

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0996-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0995-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-19
Z-0996-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-25	2023-01-19

Product code GBX

K082725Class IGraftguard Pressure Controlling SyringeMaquet Cardiovascular, LLC / cleared 2008-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)